Full Text HS-96-002
 
MEDTEP RESEARCH ON NON-CANCEROUS UTERINE CONDITIONS
 
NIH GUIDE, Volume 25, Number 6, March 1, 1996
 
RFA:  HS-96-002
 
P.T. 34, II

Keywords: 
  Urogenital System 
  Clinical Trial 

 
Agency for Health Care Policy and Research
 
Letter of Intent Receipt Date:  May 1, 1996
Application Receipt Date:  June 18, 1996
 
PURPOSE
 
The Agency for Health Care Policy and Research (AHCPR) invites
applications for cooperative agreements to design and conduct
collaborative, multi-site randomized controlled trials to compare the
effectiveness and outcomes of hysterectomy to those of other common
treatments for non-cancerous uterine conditions.  These trials will
emphasize outcomes important to patients.  The conditions of interest
are:  uterine fibroids (leiomyomata), endometriosis, dysfunctional
uterine bleeding, and uterine prolapse.
 
Each application must be submitted by the institution where the Data
Coordinating Center is located.  The Data Coordinating Center will be
the applicant and control point for project coordination, and for
management and analysis of the data.  The project should include a
consortium or network of Clinical Centers and a Study Chair.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA), MEDTEP Research on Non-Cancerous Uterine
Conditions, addresses several of those objectives.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:
Stock No. 017-001-00474-0 or Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic, non-profit organizations,
public and private, including universities, clinics, units of State
and local governments, non-profit firms, and non-profit foundations.
Racial/ethnic minorities, women, and persons with disabilities are
encouraged to apply as Principal Investigator.
 
MECHANISM OF SUPPORT
 
The administrative and funding instrument will be the cooperative
agreement (U01) in which substantial AHCPR scientific and
programmatic involvement with the awardee is anticipated during the
performance of the project.  The total project period for each
application submitted in response to this RFA may not exceed five
years.  The earliest anticipated award date is September 1, 1996.
 
FUNDS AVAILABLE
 
Dependent upon the availability of funds, AHCPR expects to award up
to $3 million to support the first year of approximately three
projects under this RFA.  The number of awards is dependent on the
number of high quality applications and their individual budget
requirements; it is not the intent of AHCPR that the awards be equal
in size. This is a one time solicitation.  Funding beyond the initial
budget period will depend upon annual progress reviews by AHCPR and
the availability of funds.
 
RESEARCH OBJECTIVES
 
Background
 
This RFA is part of AHCPR's Medical Treatment Effectiveness Program
(MEDTEP), which is a major component of the health services research
agenda of AHCPR.  MEDTEP projects assess the relative effectiveness
and costs of available interventions for the prevention, diagnosis,
treatment, and management of disease, emphasizing a broad set of
outcomes important to patients.  MEDTEP projects are patient-centered
and policy relevant; they focus on common clinical problems and
attempt to determine which clinical services and procedures are most
effective, and for whom.  In all MEDTEP work, the generalizability of
findings is emphasized.
 
Non-Cancerous Uterine Conditions
 
This RFA addresses the subject of non-cancerous uterine conditions,
specifically uterine fibroids (leiomyomata), endometriosis,
dysfunctional uterine bleeding, and uterine prolapse.  In May 1994,
AHCPR convened a public meeting to explore the important unanswered
effectiveness questions regarding the proper role of hysterectomy and
to examine research priorities in the management of non-cancerous
uterine conditions.  The meeting provided a forum for critical review
and discussion of the scientific literature and identification of the
important research questions in each of the clinical conditions
listed above.
 
There was a consensus of the meeting participants that the scientific
literature related to non-cancerous uterine conditions provides
little hard evidence of effectiveness for any of the available
treatments, and that there is a critical need for studies that would
compare the outcomes of hysterectomy to other available treatments.
Prospective applicants are encouraged to obtain a copy of the summary
of the May meeting, which includes recommendations for research and
references (See INQUIRIES).
 
The management of non-cancerous uterine conditions includes a variety
of invasive and noninvasive treatments:  surgical, pharmacologic, and
other treatments.  There has been little research demonstrating the
effectiveness of these treatments relative to each other or compared
to watchful waiting.
 
Approximately 530,000 hysterectomies are performed annually for
non-cancerous conditions, at a cost for hospitalization of over $5
billion (Wilcox, 1994).  Most of these procedures are performed for
one of several common, non-cancerous conditions that often produce
pain, discomfort, excessive uterine bleeding, emotional distress, and
related symptoms. National data for 1988-1990 reveal that most women
who undergo hysterectomy are between the ages of 35 and 54, with the
highest age-specific rate for women 35-44 (11.8 per 1,000).  By the
age of 65, over one third of U.S. women have undergone this surgery.
Except for some preliminary studies funded by AHCPR (Carlson, 1993;
Kjerulff, 1993; Kritz-Silverstein, 1994), few studies provide
information about the effects of hysterectomy on the symptoms that
lead to treatment or on the long-term outcomes that contribute to the
patient's quality of life, functional status or satisfaction with the
care received.
 
Purpose and Scope of the Activity
 
This RFA solicits studies that will directly compare the
effectiveness of hysterectomy to other common treatments for
non-cancerous uterine conditions.  AHCPR intends to initiate up to
four separate, collaborative, randomized controlled trials (RCTs)
that will compare the outcomes of hysterectomy to those of other
common treatments.  AHCPR is also interested in cost analyses of
effective treatments evaluated in the proposed trial.  Applicants
should pay special attention to defining the outcomes to be measured
and should include outcomes that are of greatest concern to women
seeking care for non-cancerous uterine conditions.  Each application
is to propose an RCT comparing hysterectomy with one or more other
treatment(s), for one of the following conditions:
 
o  Uterine fibroids
o  Endometriosis
o  Dysfunctional uterine bleeding
o  Uterine prolapse
 
Applicants may submit one or more applications, each proposing a
different RCT.
 
For each trial, the application must be submitted by the Principal
Investigator of the Data Coordinating Center, who will have
responsibility for project coordination and for the management and
analysis of the data to be collected by the Clinical Centers.  The
Study Chair will participate in the development of the proposed
study, and will provide clinical leadership to the Data Coordinating
Center and the Clinical Centers throughout the study.  The proposed
Clinical Centers should be identified and should participate in the
development of the proposed protocol, which is to be presented, in
detail, in the application.
 
The final protocol, sampling plan, and manual of operations will be
developed jointly by the Steering Committee with the assistance of
AHCPR, and will be reviewed by an independent expert group, called
the Policy and Data Monitoring Committee.  The study will move into
its operational phase (Phase 2) only with the concurrence of the
Policy and Data Monitoring Committee and AHCPR.
 
It is expected that the trials supported under this RFA will be
carried out over a period of five (5) years.  Each trial will
progress through the following phases:
 
Phase 1:  The planning phase includes the collaborative
development/refinement of the protocol and manual of operations,
including all procedures for data collection and pretesting of
procedures.  The manual of operations will include detailed plans for
the training of all personnel in study procedures.  If the final
sampling plan requires additional or different Clinical Centers to
meet patient enrollment targets, these will be recruited by the Data
Coordinating Center in Phase 1.
 
Phase 2:  Conduct of the full-scale collaborative clinical trial,
including patient recruitment and all data collection.
 
Phase 3:  Analysis of data and reporting of results.
 
SPECIAL REQUIREMENTS
 
One of the proposed Clinical Centers may be at the same institution
as the Data Coordinating Center provided that the units are
administratively and fiscally distinct.
 
Study Organization
 
1. Study Outline.  The proposed study design must include the
rationale for the treatments addressed, detailed
description/explanation of the approach to randomization, clinical
variables and patient outcomes to be studied, and an estimate of the
number of patients required in each study arm to provide convincing
evidence that the results will be statistically and clinically
significant.  Applicants should provide a detailed justification for
whatever strategy is proposed for subject selection, eligibility
requirements, inclusion and exclusion criteria for enrollment, an
estimate of the number of subjects in the source population, approach
to randomization, and an estimate of the necessary time and effort
needed for recruitment.  The approach should allow for subanalyses,
such as socioeconomic status.
 
All Clinical Centers must agree to implement the protocol and manual
of operations developed cooperatively by the Steering Committee
(defined in section 2d below) during Phase 1, and agree to transmit
all study data to the Data Coordinating Center for aggregation and
analysis.
 
2.  Study Components
 
a.  Data Coordinating Center.  The institution where the Data
Coordinating Center and the Principal Investigator are located will
be the applicant.
 
The Data Coordinating Center will have a major role in study design
and primary responsibility for project coordination, and data
management and analysis.  The Principal Investigator will oversee all
activities of the Data Coordinating Center and will have the
responsibility for the overall management of the project budget and
resource use.
 
The Data Coordinating Center will maintain a stable core of expertise
for the conduct of data management and analysis. It is desirable to
also have health services research expertise in the core.  The
Principal Investigator will serve as the primary methodologic expert
for the study. This individual should be an experienced
biostatistician, epidemiologist, physician, or other professional
with experience in directing a coordinating center for a large-scale
collaborative clinical trial.
 
The application should present a complete and detailed preliminary
trial design, including specification of hypotheses to be tested,
discussion of measures and instruments, rationale and inclusion
criteria for subject selection, how surgical versus non-surgical
patients will be managed and by whom, the plans for recruitment and
follow-up of study participants, and a data analysis plan.
 
The application should include a succinct discussion of previous
relevant experience as a coordinating center for a collaborative
trial or other large-scale epidemiological research projects,
including the implementation of systems for communication and
coordination among investigators and sites.
 
Responsibilities of the Data Coordinating Center and the Principal
Investigator include monitoring both the quality of the data and the
performance of each Clinical Center in the conduct of the protocol,
as well as ensuring the safety and confidentiality of all data.  The
applicant should discuss in detail the important management and
resource considerations for coordination of the proposed trial.
 
The Data Coordinating Center will perform interim analyses as needed
to monitor the course of the trial as well as analyses needed for
final reporting.  Preparation of progress reports, final reports, and
articles will be collaborative undertakings by the Principal
Investigator of the Data Coordinating Center, the Study Chair, and
the Clinical Centers.
 
The Principal Investigator will participate with the Study Chair, the
Clinical Centers, the Steering Committee, and AHCPR staff during the
entire clinical trial.
 
b.  Study Chair.  The Study Chair will provide clinical leadership
and research direction to the Clinical Centers and the Steering
Committee.  This individual will work actively and collaboratively
with the Principal Investigator regarding the clinical aspects of the
protocol throughout the study.  The application should include a
succinct discussion of previous relevant experience of the Study
Chair in a collaborative trial or other large scale epidemiological
research project.
 
c.  Clinical Centers.  The Clinical Centers will recruit and follow
study participants.  Each Clinical Center should consist of a core
team of researchers, gynecologists, a Clinical Director, and a
full-time Clinic/Nurse Coordinator.  Each Clinical Director should be
a gynecologist who will oversee the enrollment and follow-up of the
patients in the particular Center and coordinate the activities of
the medical team.  A full-time Clinic/Nurse Coordinator should manage
clinical aspects of the trial including logistical aspects of patient
recruitment, follow-up, survey administration, and data transmittal
to the Data Coordinating Center.
 
The Clinical Director and treatment team in each Clinical Center
should be skilled in the treatment of non-cancerous uterine
conditions as well as in collaborative clinical investigation.
 
In order to maximize the generalizability of the study results,
efforts should be made to select Clinical Centers with patient
populations that are adequate for important subanalyses, such as race
and ethnicity, income, and age. Efforts should also be made to
include Clinical Centers that provide a mix in terms of geography and
academic versus non-academic affiliations.
 
Clinical Centers will be required to submit all data expeditiously to
the Data Coordinating Center for analysis.
 
The application should describe the experience of each Clinical
Center in recruiting, studying, and treating patients with
non-cancerous uterine conditions, and the ability of each Center to
minimize loss of patients to follow-up during long-term clinical
studies.  There should be evidence of strong institutional support
for each Clinical Center, including documentation of adequate
facilities for clinical and administrative project activity. An
organizational structure for each Clinical Center should be provided
in the application delineating lines of authority and responsibility.
In addition, a statement of agreement to follow the common protocol
developed in Phase 1, and to work cooperatively with the other
Clinical Centers, the Study Chair, and the Data Coordinating Center
should be included.
 
d.  Steering Committee.  The Steering Committee will be the primary
governing body.  Managing the scientific direction of the study will
be the responsibility of the Steering Committee and its chairman,
i.e., the Study Chair.  The Steering Committee will consist of the
Principal Investigator from the Data Coordinating Center, the
Clinical Directors of each Clinical Center, the Study Chair, and the
AHCPR Project Coordinator (See Terms and Conditions).
 
e.  Policy and Data Monitoring Committee.  An independent Policy and
Data Monitoring Committee will be appointed by AHCPR.  The purpose of
this committee is to review periodically the progress of the study.
The activities of this committee will not be the responsibility of
the grantee (See Terms and Conditions).
 
f.  Project Coordinator.  AHCPR will name a staff member from the
Center for Outcomes and Effectiveness Research (COER) as the Project
Coordinator.  The functions of the Project Coordinator will be to
work closely with the Steering Committee and the Policy and Data
Monitoring Committee and provide technical assistance to assure that
the study is carried out in a rigorous and efficient manner
(described in detail under Terms and Conditions).
 
Study Phases
 
The protocol completed during the planning phase (Phase 1) will be
reviewed by the Policy and Data Monitoring Committee and AHCPR.
Progression to Phase 2 is dependent on the acceptance of the protocol
by the Policy and Data Monitoring Committee and the concurrence of
AHCPR.
 
In Phase 2, the Clinical Centers will implement the protocol
according to the manual of operations.  This will include recruiting
and randomizing patients, collecting all data specified in the
protocol, and providing all data to the Data Coordinating Center for
analysis.  All patients must be followed for a minimum of two years.
 
Phase 3 of the study will be for final data analysis, reporting of
results, and close-out of project activities.
 
Budget Preparation
 
Applicants should submit adequately justified budgets for each year
of the anticipated five year project period. Additionally, a separate
detailed budget for each subcontract is required.
 
The costs of clinical care provided to participants in this clinical
trial will not be paid out of grant funds.
 
Confidentiality of Data
 
Information obtained in the course of this study that identifies an
individual or entity must be treated as confidential in accordance
with section 903(c) of the Public Health Service Act.  Applicants
must describe in the Human Subjects section of the application
procedures for ensuring the confidentiality of identifying
information.
 
Terms and Conditions of Award
 
1.  Cooperative Activities.  The administrative and funding mechanism
to be used for this program will be the cooperative agreement (U01)
in which substantial AHCPR scientific and programmatic involvement
with the awardee(s) is anticipated during the performance of the
activity. Consistent with this concept, AHCPR will be involved
substantially in the operations and research efforts by working
collaboratively with the awardee in a partner role.
 
2.  Awardee Responsibilities.  These include development and
refinement of the study protocol and operations manual, patient
recruitment and follow-up, data collection, quality control, data
analysis and interpretation, and preparation of publications.  The
awardee agrees to finalize the common protocol and develop the manual
of operations during Phase 1 of the study.
 
3.  AHCPR Responsibilities.  AHCPR will name a Project Coordinator
from within the Center for Outcomes and Effectiveness Research, who
will work closely with the Steering Committee and Policy and Data
Monitoring Committee throughout the project.  In particular, the
AHCPR Project Coordinator will assist in quality control, review of
data analysis plans and interpretation, preparation of publications,
and coordination and monitoring of project performance.
 
The independent Policy and Data Monitoring Committee, supported by
AHCPR, will consist of individuals with expertise in relevant
medical, surgical, social science, health services research, and
methodological fields who are not directly involved in the study.
The function of this Committee will be to review periodically the
progress of the study.  Specifically, the Committee will oversee
participant safety, evaluate results, monitor data quality, and
provide operational and policy advice to the Steering Committee and
AHCPR regarding the status of the study.  Committee members will be
appointed by the Director of COER in consultation with members of the
Steering Committee.  AHCPR will assume responsibility for logistics
and costs associated with the activities of the Policy and Data
Monitoring Committee.
 
The AHCPR reserves the right to terminate or curtail the study (or
individual components) in the event of (a) a major breach in the
protocol or substantial changes in the agreed-upon protocol with
which AHCPR does not agree, or (b) unresolved human subjects/ethical
issues.
 
4.  Governance.  The primary governing body of the study will be the
Steering Committee comprised of each of the Clinical Directors of the
Clinical Centers, the Study Chair, the Principal Investigator of the
Data Coordinating Center and the AHCPR Project Coordinator.  The
Steering Committee has primary responsibility for developing the
common clinical protocol, facilitating the conduct and monitoring of
the study, and reporting the study results.  Each member of the
Steering Committee will have one vote, except for the AHCPR Project
Coordinator, who will be a non-voting member. The Study Chair will
serve as the Chair of the Steering Committee.
 
It is anticipated that the Steering Committee will meet on a monthly
basis during protocol development (Phase 1), three times a year in
Phase 2, and two times in Phase 3. Subcommittees of the Steering
Committee may be established and will meet as necessary.  The AHCPR
Project Coordinator or designee and the Data Coordinating Center will
be represented on each subcommittee.
 
5.  Arbitration.  Any disagreement that may arise in scientific
and/or programmatic matters between awardees and AHCPR may be brought
to arbitration.  An arbitration panel will be composed of three
members:  one selected by the Steering Committee (without a vote by
the AHCPR member), a second member selected by AHCPR, and a third
member selected by the preceding two members.  This special
arbitration procedure in no way affects the awardees' right to appeal
an adverse action that is otherwise appealable in accordance with the
PHS regulations at 42 CFR, Part 50, Subpart D, and DHHS regulations
at 45 CFR, Part 16.
 
The special terms of award described above are in addition to and not
in lieu of otherwise applicable PHS grant policies and Federal
regulations.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH STUDY POPULATIONS
INVOLVING HUMAN SUBJECTS
 
Since this RFA deals only with issues affecting women, the following
applies to the inclusion of minorities in the study population.
 
It is the policy of AHCPR that women and members of minority groups
be included in all AHCPR supported research projects involving human
subjects, unless a clear and compelling rationale and justification
are provided that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research.
 
The NIH policy resulting from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43) supersedes and strengthens NIH's
previous policies (Concerning the Inclusion of women in Study
Populations, and Concerning the Inclusion of Minorities in Study
Populations), which were in effect since 1990 and which AHCPR had
adopted.  The new NIH policy contains provisions that are
substantially different from the 1990 policies.  All investigators
proposing research involving human subjects should read the "NIH
Guidelines on the Inclusion of Women and Minorities as Subjects in
Clinical Research," which was published in the Federal Register of
March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE FOR
GRANTS AND CONTRACTS of March 11, 1994, Volume 23, Number 10.  AHCPR
follows the revised NIH Guidelines, as applicable.
 
Investigators may obtain copies from those sources or from the AHCPR
contractor, Global Exchange, listed under INQUIRIES.  AHCPR program
staff may also provide information concerning this policy (See
INQUIRIES).
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by May 1, 1996, a letter
of intent that includes the name, address, and telephone number, of
the proposed Principal Investigator and other key personnel; the
identities of proposed consortia members, including any other
participating organizations or institutions; a descriptive title of
the proposed trial(s); and the number and title of this RFA.
 
Although a letter of intent is not required, is not binding, and does
not enter into the consideration of any subsequent application, the
information allows AHCPR staff to estimate the potential review
workload and avoid conflicts of interest in the review.  AHCPR will
not provide responses to letters of intent.
 
Letters of intent are to be addressed to:
 
Center for Outcomes and Effectiveness Research
Attention:  Ms. Joanne Book
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Email:  COER_RFA@PO4.AHCPR.GOV
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  State and local government applicants
may use form PHS-5161-1, Application for Federal Assistance (rev.
9/92), and follow those requirements for copy submission.  These
forms are available at most institutional offices of sponsored
research and may be obtained from the Office of Extramural Outreach
and Information Resources, National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD  20892-7910, telephone
301/435-0714, email:  girg@drgpo.drg.nih.gov.
 
AHCPR applicants are encouraged to obtain application materials from
the AHCPR contractor Global Exchange, Inc., 7910 Woodmont Avenue,
Suite 400, Bethesda, MD  20814-3015; telephone 301/656-3100 or FAX
301/652-5264.
 
The RFA label available in the form PHS 398 (rev. 5/95) must be
affixed to the bottom of the face page of the original application.
Failure to do so could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, in item 2 on the face page of the
application, mark the "YES" box and enter "RFA HS-96-002" and the
title.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must be sent to:
 
Miriam A. Kelly, Ph.D.
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
 
Applications submitted under this RFA must be received in the
Division of Research Grants, NIH, by June 18, 1996.  If an
application is received after that date, it will be returned to the
applicant without review.
 
Seminar for Prospective Applicants
 
AHCPR plans to convene a special technical assistance workshop to
assist potential applicants, especially those with limited experience
with the application process.  The purpose of this seminar is to give
background information and respond to any questions about the
preparation of an application in response to this RFA.  The workshop
will be held in the Rockville/Bethesda, Maryland area approximately
one month after the publication of this announcement. Attendance is
not a prerequisite to applying.  Attendees must pay for their own
travel and accommodation costs.  The workshop will be open to any
individual or organization wishing to attend.  A synthesis of
pertinent Questions and Answers discussed at the prospective
applicants meeting will be available from the AHCPR contractor,
Global Exchange, Inc., listed under INQUIRIES.  For further
information contact Dr. Mim A. Kelly, at the mailing/internet address
listed under INQUIRIES.
 
REVIEW CONSIDERATIONS
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened in accordance with AHCPR peer review
procedures.  As part of the merit review, all applications will
receive a written critique, and also may undergo a process in which
only those applications deemed to have the highest scientific merit
will be discussed and assigned a priority score.  Recommendations of
the peer review committee may be reviewed subsequently by AHCPR's
National Advisory Council.
 
General Review Criteria
 
Review criteria for AHCPR grant applications are: significance and
originality from a scientific and technical viewpoint; adequacy of
the method(s); availability of data or proposed plan to collect data
required for the project; qualifications and experience of the
Principal Investigator and proposed staff; adequacy of the plan for
organizing and carrying out the project; reasonableness of the
proposed budget; and adequacy of the facilities and resources
available to the applicant (See also Special Review Criteria).
 
Special Review Criteria
 
In addition to the general criteria above, the reviewers will assess
the application in terms of the SPECIAL REQUIREMENTS of this RFA,
including:
 
o  adequacy of the proposed study design to address the objectives of
the RFA, including criteria for subject selection, plans for
recruitment of subjects, proposed follow-up assessments and schedule
for data collection during follow-up, proposed diagnostic and
therapeutic modalities, proposed outcomes measures, proposed cost
analyses, and techniques for monitoring and maintaining continued
contact with subjects during the course of the study;
 
o  ability to recruit and involve Clinical Centers that have the
experience and capacity to select, treat, manage, retain, and follow
a sufficient number of subjects for the study proposed;
 
o  clinical experience and research expertise of the Study Chair in
the diagnosis, treatment and management of non-cancerous uterine
conditions, and demonstrated leadership ability in the conduct of
large clinical studies;
 
o  documentation of specific competence and previous experience of
the professional, technical, and administrative staff pertinent to
the operation of the Data Coordinating Center, working in
collaboration with other investigators under a common protocol, and
experience with careful and expeditious handling of study data;
 
o  prior experience in the collection, management, quality control,
and analysis of data from multiple clinical sites;
 
o  prior experience in developing a detailed manual of operations and
forms for multicentered clinical trials;
 
o  evidence of substantive institutional commitment and support for
the proposed project; and
 
o  willingness to work cooperatively in the manner summarized above.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other
applications under this RFA.  The following will be considered in
making the funding decisions:  quality of the proposed project as
determined by peer review, program balance, and availability of
funds.
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
Copies of the RFA, the related background conference summary, and a
bibliography are available from:
 
Global Exchange Inc.
7910 Woodmont Avenue, Suite 400
Bethesda, MD  20814-3015
Telephone:  (301) 656-3100
FAX:  (301) 652-5264
 
Copies of the RFA and the background conference summary document
(AHCPR Pub. No. 95-0067, July, 1995) can also be requested through
e-mail at COER_RFA@PO4.AHCPR.GOV and through AHCPR InstantFAX at
301/594-2800.  To use InstantFAX, you must call from a facsimile
(FAX) machine with a telephone handset.  Use the key pad on the
receiver when responding to prompts from InstantFAX.  The RFA will be
sent at the end of the ordering process.  AHCPR InstantFAX operates
24 hours a day, 7 days a week.  For questions about this service,
call AHCPR's Division of Communications at 301/594-1364 ext. 159.
 
Direct inquiries regarding programmatic issues, including information
on the policy of inclusion of women and minorities in study
populations, to:
 
Miriam A. Kelly, Ph.D.
Center for Outcomes and Effectiveness Research
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 605
Rockville, MD  20852-4908
Telephone:  (301) 594-1485
Email:  COER_RFA@PO4.AHCPR.GOV
 
Direct inquiries regarding fiscal matters to:
 
Carol Roache
Acting Chief, Grants Management Staff
Agency for Health Care Policy and Research
2101 East Jefferson Street, Suite 601
Rockville, MD  20852-4908
FAX:  (301) 594-3210
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance Number 93.180.  Awards are made under authorization of
Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and
Section 1142 of the Social Security Act (42 U.S.C. 1320b-12).  Awards
are administered under the PHS Grants Policy Statement and Federal
regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 92.  This
program is not subject to the intergovernmental review requirements
of Executive Order 12372.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, The Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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